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Head of Regulatory Affairs, Oncology - Palo Alto, United States - Ascendis Pharma
Description
We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncology.Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We are a dynamic workplace for employees to grow and develop their skills.This position will be responsible for developing and implementing global regulatory strategies in Oncology. Ensures compliance with all applicable policies and global regulatory requirements in a timely manner. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. Mentors and supervises other regulatory professionals working on the project team and regulatory process-related topics. Requires ability to work strategically, both independently and in a team environment. The position will be based in Palo Alto, CA.
Key Responsibilities
Responsible for overarching strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members and regulatory colleagues
Contributes to the development of global clinical regulatory plans and strategies; identifies and proposes risk mitigation strategies; influences project teams and sub teams across international site locations
Provides regulatory information and guidance for product development and planning throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure compliance and product expansion
Acts as the company representative with regulatory authorities
Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs
Must be willing to provide hands-on, study level help as needed in addition to oversee direct reports
Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines
Maintains up-to-date knowledge of highly complex regulatory requirements and communicates changes in regulatory information to project teams
Work is performed under direction of the Head of Clinical Development, Oncology
Contributes to internal regulatory policies and procedures to achieve best practices and work processes
BS/BA Degree in a Scientific Discipline required. Advanced Degree preferred
Minimum of 15 years in the biopharmaceutical industry with at least 10 years overall regulatory experience (with at least 6 of those years in Oncology)
Prior Senior Management experience representing Regulatory Affairs on cross-functional teams is desirable.
Must have hands-on experience in successfully leading cross-functional teams for submissions of regulatory dossiers including CTAs, IMPDs, INDs; experience with BLAs/NDAs/MAAs in solid tumors are required; accelerated approval experience a plus
Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business
Must be capable of critically reviewing complex technical documents and influencing colleagues across functions
Ability to travel up to 10-20% of the time domestically and internationally
Estimated compensation:
$320-350K/year
A note to recruiters:
We do not allow external search party solicitation.
Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid maternity leave
Paid paternity leave
Commuter benefits
Disability insurance
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